The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

Device Description

The NeoMed Oral / Enteral Syringe is specifically designed for administration of enteral liquids to neonatal and small pediatric patients. The NeoMed Oral / Enteral Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Oral / Enteral Syringes are compatible with NeoMed enteral-only connectors, the NeoMed extension sets and NeoMed feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteral/feeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Oral / Enteral Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Oral / Enteral Syringes possess design features that prevent connectivity to luer type devices and hence prevents the chance that a feeding tube could be infused into the IV line.

The NeoMed Oral / Enteral Syringe device consists of the following components:

Syringe Barrel
Syringe Plunger
Syringe Gasket
Syringe Tip
Syringe Cap

AI/ML Overview

Here's an analysis of the provided text regarding the NeoMed Oral / Enteral Syringe, focusing on the acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from text)	Reported Device Performance
Compliance with ISO 7886-1	Design verification testing has demonstrated the NeoMed Oral / Enteral Syringes "meet the applicable requirements of ISO 7886-1."
Compliance with ISO 7886-2	Design verification testing has demonstrated the NeoMed Oral / Enteral Syringes "meet the applicable requirements of ISO 7886-2."
Compliance with ISO 10993-1 (biocompatibility)	"The NeoMed Oral / Enteral Syringe materials that come in direct contact with the patient have a long history of use in syringe manufacturing and are biocompatible according to ISO 10993 test results." Also, "have the same materials which comply with ISO10993-1 as applicable to the intended use of the device."
Sterility Assurance Level (SAL) of 10^-6^	"are sterilized to Sterility Assurance Level (SAL) of 10-6."
Equivalent performance to predicate device	"demonstrate equivalent performance during design verification testing." Specifically, "Design Verification testing as a result of the risk analysis has demonstrated that the NeoMed Oral / Enteral Syringes ranging from 0.5mL to 100mL are functionally equivalent to predicate NeoMed Sterile Syringes."
Compliance with ISO 80369-1	"meet the applicable requirements of ISO 80369-1."
Extended size range does not affect safety or effectiveness	"the new range of sizes do not affect safety or effectiveness when compared to the predicate device." And "the extended size range from the predicate does not affect safety or effectiveness."
Perform as intended (dispenser, measuring, fluid transfer)	"Design verification test results demonstrate that the NeoMed Oral / Enteral Syringe performs as intended."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" for the test set in terms of a number of units tested. It refers broadly to "Design Verification testing" and "test results." The data provenance is implied to be from internal testing conducted by NeoMed, Inc. and is therefore prospective for the device being submitted. There is no information regarding country of origin of the data beyond the manufacturer's location in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document refers to "Design Verification testing" and "risk analysis," which implies engineering and technical testing against established standards, rather than clinical ground truth established by medical experts for a diagnostic or treatment outcome.

4. Adjudication Method for the Test Set

This information is not provided as the "test set" appears to refer to engineering and performance testing against standards, not a clinical study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted. This is a medical device (syringe) and the submission focuses on its physical and functional performance, biocompatibility, and sterility, not on diagnostic or AI-assisted clinical interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a physical syringe, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this device is based on engineering and performance standards (e.g., ISO 7886-1, ISO 7886-2, ISO 10993-1, ISO 80369-1) and the established performance of the predicate device (K092908). The testing verifies that the physical properties, functionality, and biocompatibility meet these predefined benchmarks, rather than clinical outcomes or expert diagnoses.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

Summary

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K122373

510K Summary of Safety & Effectiveness

July 30, 2012

NEOMED

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	NeoMed, Inc.
	FDA Owner/Operator #10022926
	Establishment Registration #3006520777
	100 Londonderry Court
	Suite 112
	Woodstock, GA 30188
	Tony Lair, President
	Tel: 770-516-2225
	Fax: 770-516-2448
	Email: lair1@concentric.net
OFFICIALCORRESPONDENT	Melinda Harrison, RAC
	NeoMed, Inc.
	Director of Quality and Regulatory Affairs
	100 Londonderry Court
	Suite 112
	Woodstock, GA 30188
	Tel: 770-516-2225
	Fax: 770-516-2448
	Email: mharrison@neomedinc.com
TRADE NAME:	NeoMed Oral / Enteral Syringe (0.5ml to 100ml)
CLASSIFICATIONNAME:	Piston Syringe
DEVICECLASSIFICATION	Class II per 21 CFR §880.5560
PRODUCT CODE	FMF
PREDICATEDEVICE NAME	NeoMed Sterile Syringe (K092908)

SUBSTANTIAL EQUIVALENCE:

The principle device of this 510(k) premarket notification is the result of device modification (increase of product family size range) to the predicate device K092908 which were conducted in accordance with Quality System Regulations, 21 CFR 820.

The NeoMed Oral / Enteral Syringes ranging from 0.5ml to 100ml are substantially equivalent to the predicate device, given that both the principle and predicate devices:

have the same indications for use ●
- have the same method of operation to dispense, measure and transfer fluids

Special 510(K)NeoMed, Inc.	NeoMed Oral / Enteral SyringeConfidential
--------------------------------	-----------------------------------------------

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meet the applicable requirements of ISO 7886-1 and ISO 7886-2 .
have the same materials which comply with ISO10993-1 as applicable to the . intended use of the device
are sterilized to Sterility Assurance Level (SAL) of 10-6 .
demonstrate equivalent performance during design verification testing .
meet the applicable requirements of ISO 80369-1 .

Design Verification testing as a result of the risk analysis has demonstrated that the NeoMed Oral / Enteral Syringes ranging from 0.5mL to 100mL are functionally equivalent to predicate NeoMed Sterile Syringes and the new range of sizes do not affect safety or effectiveness when compared to the predicate device.

DESCRIPTION OF THE DEVICE:

The NeoMed Oral / Enteral Syringe is specifically designed for administration of enteral liquids to neonatal and small pediatric patients. The NeoMed Oral / Enteral Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices . The NeoMed Oral / Enteral Syringes are compatible with NeoMed enteral-only connectors, the NeoMed extension sets and NeoMed feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteral/feeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Oral / Enteral Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Oral / Enteral Syringes possess design features that prevent connectivity to luer type devices and hence prevents the chance that a f eeding tube could be inf used into the IV line.

The NeoMed Oral / Enteral Syringe device consists of the following components:

Syringe Barrel
Syringe Plunger
Syringe Gasket
Syringe Tip
Syringe Cap

INDICATIONS FOR USE:

PERFORMANCE DATA: .

The NeoMed Oral / Enteral Syringe materials that come in direct contact with the patient have a long history of use in syringe manufacturing and are biocompatible according to ISO 10993 test results. Design verification test results demonstrate that the NeoMed Oral / Enteral Syringe performs as intended and the extended siz e range from the predicate does not affect safety or effectiveness.

CONCLUSION:

Based on the method of operation, indications for use, materials of construction and performance testing, it can be concluded that the NeoM ed Oral / Enteral Syringes ranging i from 0.5ml to 100ml are equivalent to the predicate NeoMed Sterile Syringe with respect to intended use and technological characteristics.

Special 510(K) NeoMed, Inc.

NeoMed Oral / Enteral Syringe Confidential

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a protective shape over a group of people.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP
2 0
2012

NeoMed, Incorporated Ms. Melinda Harrison Director of Quality and Regulatory Affairs 100 Londonderry Court, Suite 112 Woodstock, Georgia 30188

Re: K122373

Trade/Device Name: NeoMed Oral / Enteral Syringe (0.5ml to 100ml) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 30, 2012 Received: September 4, 2012

Dear Ms. Harrison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Harrison

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Dt. Steele
Smether.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: NEOMED ORAL / ENTERAL SYRINGE

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mld Chape 9/12/12

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K12237

Page 1 of

Special 510(K) NeoMed, Inc.

NeoMed Oral / Enteral Syringe Confidential

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).